Multiple States, 2006 COURSE DESCRIPTION

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1 Multiple States, 2006 COURSE DESCRIPTION Keratitis occurs when the cornea is inflamed. This Continuing Education module discusses a 2006 multi-state outbreak of keratitis caused by Fusarium, a type of fungus. The majority of individuals infected with Fusarium were contact lens wearers. The outbreaks lead to a recall of contact lens solutions. As of October 2006, the Centers for Disease Control and Prevention (CDC) is still studying the cause and effect of the outbreaks. Rev 2.0 2/2008 1

2 COURSE TITLE: Fusarium Keratitis, Multiple States, 2006 Author: Centers for Disease Control & Prevention and Lucia Johnson, MA, CLS(NCA), MT(ASCP)SBB Director of Continuing Education National Center for Competency Testing Number of Clock Hours Credit: 2.0 Course # P.A.C.E. Approved: Yes X No Upon completion of this continuing education module, the professional should be able to: 1. Define keratitis. 2. Identify causes of keratitis. 3. Describe symptoms of keratitis. 4. Describe how Fusarium is identified. 5. List six safe contact lens practices. 6. Identify risk factors for infection by microbial keratitis. 7. List treatment options for keratitis. 8. State the number of patients that, as of April 9, 2006, were under investigation by the CDC for suspected Fusarium keratitis. 9. State the number and percentage of patients in the CDC investigation that were contact lens wearers. 10. List the name of the contact lens solution manufacturer that voluntarily recalled a solution that appears to be involved in the keratitis outbreak. 11. Identify the states and countries that have reported cases of Fusarium keratitis. Disclaimer The writers for NCCT continuing education courses attempt to provide factual information based on literature review and current professional practice. However, NCCT does not guarantee that the information contained in the continuing education courses is free from all errors and omissions. 2

3 INTRODUCTION TO MMWR ARTICLE Keratitis is a condition in which the cornea of the eye is inflamed. Superficial keratitis involves the superficial layers of the cornea. Deep keratitis involves the deeper layers of the cornea. Superficial keratitis generally does not leave a scar on the cornea. However, deep keratitis may leave scars that impair vision. Microorganisms such as bacteria, viruses, fungus, and parasites may cause keratitis. It may also be caused by exposure to harmful chemicals, ultraviolet radiation exposure, and eye trauma. Symptoms of keratitis include inflammation of the conjunctiva that causes a very red eye, sensitivity to light, and a feeling that something is in the eye. In more severe cases, there can be pain, blurry vision, loss of vision, and the formation of pus. Keratitis caused by Fusarium Photograph courtesy of This picture is best viewed in color from the webpage or the Continuing Education CD-ROM. Effective treatment of keratitis depends on the cause. If a microorganism causes it, the appropriate antibacterial, antifungal, or antiviral therapy must be given. Prescription medications may include eye drops, pills, or even intravenous therapy. If the keratitis leads to scarring of the cornea, vision may be limited. Corneal transplantation may be required if the eye becomes severely scarred. In the most serious cases, the cornea may perforate, the infection may spread to the inside of the eye, or the eye may have to be removed. In the MMWR article that follows, a fungus named Fusarium is causing an outbreak that appears to be related to the use of certain contact lens solutions. The genus Fusarium consists of over 20 species. These organisms are widely distributed on plants and in the soil. Diagnosis: To diagnose a Fusarium infection, scrapings of the cornea are sent to the laboratory for culture. Almost all Fusarium species grow rapidly in the laboratory when cultured on the appropriate culture media. If no growth has occurred on the media within 14 days, the culture is negative for Fusarium. A laboratory specialist who is knowledgeable about fungal culture and identification must perform macroscopic and microscopic evaluation of the fungal colonies to confirm the identity. 3

4 Culture of Fusarium. Growth of the organism is generally rapid. The fungal colony is usually pink to violet. Photograph courtesy of This picture is best viewed in color from the webpage or the Continuing Education CD-ROM. Microscopic appearance of Fusarium Photograph courtesy of This picture is best viewed in color from the webpage or the Continuing Education CD-ROM. Treatment: Fusarium is one of the more drug-resistant fungi and is, therefore, difficult to treat. Amphotericin B, voriconazole, and natamycin are the antifungal drugs most commonly used. Preventing fungal keratitis: Safe handling, storage and cleaning of contact lenses are key measures for reducing the risk of infection. The American Academy of Ophthalmology recommends consumers always use the following safe contact lens practices: Wash your hands with soap and water and dry them before handling lenses. Wear and replace your lenses according to the schedule prescribed by your doctor. Follow instructions from your doctor and your solution manufacturer for cleaning and storing your lenses. Make sure you always use fresh solution and replenish the solution daily. Keep your contact lens case clean and replace every three to six months. Remove the lenses and consult an ophthalmologist immediately if your eyes become red or irritated or your vision changes. Regardless of what cleaning/disinfecting solution you use, consider performing a rub and rinse lens cleaning method rather than a no-rub method to minimize the number of microorganisms, reducing your chances of infection. 4

5 NOTE: The following article was in the April 14, 2006, 2006/Vol.55/No.14 Morbidity and Mortality Report. The article was prepared by the Centers for Disease Control and Prevention (CDC) and was printed and distributed by the Massachusetts Medical Society, publishers of The New England Journal of Medicine. The following MMWR article describes the development of a fungal infection in contact lens wearers. As this outbreak is still under investigation, following the report, a CDC update from May 9, 2006 is given. Fusarium Keratitis Multiple States, 2006 On March 8, 2006, CDC received a report from an ophthalmologist in New Jersey regarding three patients with contact lens-associated Fusarium keratitis during the preceding 3 months. Initial contact with several corneal disease specialty centers in the United States revealed that other centers also have seen recent increases in Fusarium keratitis. This report summarizes the public health response to date in the United States and provides important prevention messages for contact lens users. Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and rarely, contact lens use (1-3). An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users, depending on whether users wear lenses overnight (4). Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, up to 35% of microbial keratitis cases are fungal keratitis, compared with 1% in New York (5,6). The proportion of fungal keratitis attributable to Fusarium spp. also varies by region, from 25% to 62% (1,2,5). First-line treatment includes topical and oral antifungal medications; patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation (3). Fusarium keratitis is not transmitted from person to person. As of April 9, 2006, a total of 109 patients with suspected Fusarium keratitis were under investigation in multiple states. Case finding was conducted through postings on the Epidemic Information Exchange (Epi-X) and ophthalmology listservs and through queries of clinical microbiology laboratories. CDC is coordinating an investigation with public health authorities in California, Connecticut, Florida, Georgia, Iowa, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, and Vermont. The majority of patients have yet to be interviewed; however, of 30 patients for whom complete data were available, the median age was 48 years (range years), and 21 (70%) were female; infection onset occurred during June 15, 2005 March 18, Twenty-eight patients (93%) wore soft contact lenses, and two (7%) reported no contact lens use. Among contact lens users, 26 (93%) remembered which solution they used during the month before infection onset or had retained the actual bottle. Of these, 26 (100%) reported using a Bausch & Lomb (Rochester, New York) ReNu brand contact 5

6 lens solution or a generic-brand solution manufactured by Bausch & Lomb. Patients reported using various ReNu product types from multiple product lots. Five (18%) patients reported using other solutions in addition to the ReNu solution, including solutions made by Advanced Medical Optics, Inc. (Santa Ana, California) and Alcon (Fort Worth, Texas). Nine (32%) patients reported wearing contact lenses overnight, a known risk factor for microbial keratitis. Eight (20%) required corneal transplantation. Laboratory testing to evaluate product contamination, including typing of Fusarium spp. isolates, is ongoing. Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in February At that time, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong, pending investigation, after multiple reports of Fusarium keratitis among contact lens users there. An ongoing investigation by CDC, state and local health departments, and the Food and Drug Administration is under way to determine whether this cluster represents an increase of Fusarium keratitis infections and to determine the association, if any, of these cases with any product. Epidemiologic and laboratory studies will help define specific activities, hygiene practices, or products that place persons at increased risk for Fusarium keratitis. Measures to reduce the risk for microbial keratitis can be instituted immediately by contact lens users and include the safe handling, storage, and cleaning of contact lenses. Specifically, contact lens users should wash their hands with soap and water and dry them before handling lenses, wear lenses according to the schedule prescribed by eye-care practitioners and solution manufacturers, and follow guidelines for cleaning and storing lenses provided by eye-care practitioners and solution manufacturers. Contact lens users with questions about which solutions are best for them should consult their eye-care professionals and carefully weigh risks and benefits. Clinicians evaluating contact lens users with signs or symptoms of keratitis, such as unusual redness, eye pain, tearing, discharge, or sensitivity to light, should consider fungal keratitis and refer the patient to an ophthalmologist, if appropriate. Clinicians should consider obtaining clinical specimens (e.g., corneal scrapings) for culture before initiating treatment. Clinicians or microbiology laboratories should report cases of Fusarium keratitis to state and local health departments or directly to CDC by telephone, Fusarium isolates should be submitted to state laboratories according to instructions provided by local and state public health laboratories. Reported by: MA Berry, MD, J Pendarvis, MPH, Boston Public Health Commission. J Rosenberg, MD, S Chen, MPH, California Dept of Health Svcs. P Mshar MPH, Connecticut Dept of Public Health. F Leguen, MD, Miami-Dade County Health Dept. C Robertson, MD, C Genese, MBA, C Tan, MD, E Bresnitz, MD, New Jersey Dept of Health and Senior Svcs. G Johnson, M Anand, MPH, P Smith, MD, New York State Dept of Health, MA Kainer, MPH, Tennessee Dept of Health. J Saviola, OD, M Eydelman, MD, D Schultz, MD, Food and Drug Admin. K O Donnell, PhD, US Dept of Agriculture. BJ Park, MD, A Srinivasan, MD, K Wannemuehler, MS, M Arduino, PhD, J Noble-Wang, PhD, L Jacobson, M Brandt, PhD, S Fridkin, MD, National Center for Infectious Diseases; D Chang, MD, LA Burwell, MD, LR Carpenter, DVM, FMT Lewis, MD, JK Schaffzin, MD, PhD, L Sosa, MD, EIS officers, CDC. 6

7 Centers for Disease Control and Prevention Fusarium Keratitis Update May 9, 2006 The CDC is continuing its investigation on the multi-state outbreak of Fusarium keratitis that may be associated with contact lens use. As of May 9, 2006, CDC has received reports of 106 confirmed cases, 12 possible cases, and 80 cases are still under investigation from 32 U.S. states and territories. Sixty-nine reports include insufficient evidence to classify them as cases or carry other non-fusarium diagnoses. States or territories with at least 1 confirmed or possible case include: Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, and Vermont. States where all cases are under investigation include: Indiana, Minnesota, Mississippi, Nevada, Oregon, and Rhode Island. Not all data are available for all confirmed cases. However, as of May 9, 2006, of the 98 confirmed cases for which CDC has complete data: 5 (5%) did not wear contact lenses (no solution used) 93 (95%) wore contact lenses o 59 (63%) reported using any Bausch & Lomb ReNu with MoistureLoc o 19 (20%) reported using any Bausch & Lomb ReNu MultiPlus o 9 (10%) reported using any unspecified Bausch & Lomb ReNu o 3 (3%) reported using any Advanced Medical Optics o 4 (4%) reported using any Alcon product *Some cases reported using more than one type of solution and therefore the solution categories are not mutually exclusive. Summary and Clarifications In addition, CDC would like to clarify some of the information that has appeared in a number of recent media stories on the outbreak. The following information is known related to this outbreak: Since the first report on this outbreak in the April 10, 2006 Morbidity and Mortality Weekly Report (MMWR), CDC has noted that patients have reported using multiple products, including those manufactured by Bausch & Lomb, Alcon, and Advanced Medical Optics, Inc. At this point, it is too early in the investigation to say whether a particular product or solution may be responsible for the outbreak. Throughout the investigation, the proportion of patients who reported using Bausch and Lomb s ReNu with MoistureLoc has remained relatively consistent, at around percent of confirmed cases. 7

8 Since solution bottles were often not available to investigators, reported solution usually reflects patient recall of specific product used during the 30 days before infection. No inferences about causes of infection should be made until additional analyses are completed. ReNu with MoistureLoc was used by approximately 2.3 million contact lens wearers in the United States, while MultiPlus was used by nearly 11 million contact lens wearers (branded or private label). Fusarium keratitis is a naturally occurring disease in the United States. It is not a disease that healthcare providers must report so it is unclear how many cases occur each year in the United States. Disease outbreaks and increased media coverage often raise awareness about particular infections, which, in turn, may 1) increase reports of disease and 2) result in additional information being identified and collected. Thus, it is possible that some of the cases currently being investigated represent infection which might normally occur and, as a result, are not related to the outbreak. The risk of getting fungal keratitis from contact lenses remains extremely low. Contact lens wearers who experience unusual redness, pain, tearing, light sensitivity, blurry vision, discharge or swelling should consult their doctor immediately. CDC is continuing its investigation into identifying whether there are specific factors that may have placed people at risk for developing fungal keratitis, including hygiene practices, overnight contact lens wear and specific solutions used. The CDC will provide more information as it becomes available. For more information on fungal keratitis and advice to doctors and consumers, please visit or References Rosa RH Jr, Miller D, Alfonso, EC. The changing spectrum of fungal keratitis in south Florida. Ophthalmology 1994; 101: Tanure MA, Cohen EJ, Sudesh S, Rapuano CJ, Laibson, PR. Spectrum of fungal keratitis at Wills Eye Hospital, Philadelphia, Pennsylvania, Cornea 2000; 19: Thomas PA, Fungal infections of the cornea. Eye 2003; 17: Poggio EC, Glynn RJ, Schein OD, et al. The incidence of ulcerative keratitis among users of daily-wear and extended-wear soft contact lenses. New Eng J Med

9 321: Liesegang TJ, Forster PK. Spectrum of microbial keratitis in South Florida. Am J Ophthalmol 1900;90: Asbell P, Stenson S. Ulcerative keratitis, Survey of 30 years; laboratory experience. Arch Ophthalmol 1982; 100: Singapore Ministry of Health. Increasing incidence of contact lens related fungal corneal infections (update 3). February 21, Available at newsroom/pressreleases;details.do?id= TEST QUESTIONS Fusarium Keratitis # Directions: Before taking this test, read the instructions on how to complete the answer sheets correctly. If taking the test online, log in to your User Account on the NCCT website Select the response that best completes each sentence or answers each question from the information presented in the module. If you are having difficulty answering a question, go to and select Forms/Documents. Then select CE Updates and Revisions to see if course content and/or a test questions have been revised. If you do not have access to the internet, call Customer Service at Which one of the following is NOT a cause of keratitis? a. chemicals b. hay fever c. microorganisms d. trauma 2. Symptoms of keratitis include. a. eye twitches b. fever c. headache d. sensitivity to light 3. The microorganism being investigated by the CDC as causing the keratitis outbreak is a/an. a. bacteria b. fungus c. parasite d. virus 9

10 4. Keratitis may scar the cornea so badly that a cornea transplant may be required. a. True b. False 5. The microorganism causing the outbreak of keratitis under investigation by the CDC is. a. Cornarium b. Eyesarium c. Fusarium d. Keratarium 6. The microorganism causing the outbreak of keratitis under investigation by the CDC is difficult to treat because. a. it is hard to identify b. it is resistant to drugs c. people with infections do not see the doctor until it is too late to treat d. all answers are correct 7. Which one of the following is a safe handling and use of practice for contact lenses wearers? a. change solution in the contact lens case every week b. replace the contact lens case every three to six months c. use hand sanitizer to clean your hands before handling solutions d. wear your lenses until one is torn 8. How many patients were under investigation for Fusarium keratitis as of April 9, 2006? a. 109 b. 119 c. 129 d What percentage of people under investigation by the CDC as of April 9, 2006 wore soft contact lenses? a. 7% b. 18% c. 93% d. 100% 10

11 10. The keratitis outbreak under investigation by the CDC has been found in 32 United States and territories as well as. a. East and West Germany b. Singapore and Hong Kong c. Trinidad and Tobago d. West Africa 11. Which one of the following manufacturers of contact lens solutions have been under investigation by the CDC as a possible cause of the keratitis outbreak? a. Advanced Medical Optics b. Alcon c. Bausch and Lomb d. All answers are correct 12. Some individuals involved in the CDC keratitis outbreak investigation do not wear contact lenses. a. True b. False *End of Test* 11

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